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Friday, 14 May 2010

It is now known that Brazil and India are each launching complaints to the World Trade Organization regarding the seizure within the European Union territory of generic pharma products which, being made in India and destined for Brazil, were not put on to the market in the EU. Describing the casus belli on the IP Tango weblog, the IPKat's friend José Carlos Vaz e Dias writes:

"The conflicts involving Brazil started back in November/December 2009 when a shipment of 500 kilos of the generic drug Losartan® was seized at the Rotterdam port. The cargo left India with Brazil as its final destination, but had a stop over at the Rotterdam Port. Soon after the Dutch customs authorities realized that the generic drugs manufactured in India had existing valid patents for Losartan® in the EU, they informed the company that holds the patents for that drug - Merck Sharp & Dohme - which quickly obtained an injunction to restrain the importation transit procedure".

The IPKat keeps getting puzzled by all of this. He's not sure precisely where in India the generic Losartan is made, but he has looked carefully at his atlas and it does appear to him that Rotterdam is not terribly close to even the nearest bit of India. And, while Rotterdam is great for transportation purposes because it's on a big river and by the sea, there's no convenient overland passage from India. He believes that Losartan doesn't have an indefinite shelf life and that, therefore, it's a good idea to get it to its destination sooner rather than later. Also, it's not as if the cargo is coal: it was just 500kg of the stuff that was seized in transit. That's surely a good deal lighter than the Indian cricket team, which generally goes by air ...

Merpel adds, since Latin America is such a big market for generic pharma products, why doesn't India -- which knows a thing or two about outsourcing -- outsource some of its for-export pharma manufacture to a local Latin American firm?

The wonderful part about humans is that they are somewhat denser than a packet of pharmaceuticals, so 500kg of humans require somewhat less space.

Imagine a box of drugs. Imagine how much more a piece of meat that size would weigh in comparison.

Then imagine how big a space would be needed for 500 kilos of boxed pharmaceuticals. I would imagine air travel would be expensive for such freight given the space required.

I am not a transporter of drugs, but I would imagine that it is somewhat cheaper to transport from India to Rotterdam along an existing route, then Rotterdam to Brazil along a route, than to charter a boat to transport the drugs. Given that these drugs are generic, possibly low-cost drugs, the cost issue is large.

Of course I could be completely wrong on that, and I'm very happy to be corrected...

I'm not too sure that I can explain, but it suggests to me that anyone with a European validation issue seriously considers The Netherlands. Whilst Dutch renewal fees can be on the steep side, you only need to have the claims translated nowadays.

One of my clients did not have enough money to validate their European Patent in each and every country that had been designated - in the days when one needed to do this - and they did not validate in The Netherlands.

Now many shipments of product arrive in The Netherlands, from China and the Far East. The European Market is effectively borderless in that EU border customs officer will check that you paid tax......

Whilst there is provision for Cross Border IP control and certain countries such as the United Kingdom discharge their duties properly (although one needs to pay a fee and inform the customs directly) it is known that this is not the case for all EU borders.

I would like to know how did the Customs got hold of the shipment. If it was on the route from outside of EU to outside of EU it should never had passed the EU customs. Or was the Spediteur stupid enough not to leave it in customs free warehouse even if loading and unloading took place.

With regard to patent free coutries and customs. According to EU regulations you do not need to go through the customs at the point of entry into EU but you have 48 hours to do it. E.g. a german custommer from Aachen (who gets his products via Rotterdam or Antwerpen) prefers to do the customs procedure in Germany within 48 hours after unloading in Port rather than having a legal person in NL or BE and have to do the customs papers in dutch.

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